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| Name | Class |
|---|---|
| Paul Hartmann | UNKNOWN |
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The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrosorb® arm | Experimental | Hydrogel Hydrosorb® |
|
| Placebo arm | Placebo Comparator | Castalie water spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Castalie water spray | Device |
| ||
| Hydrogel Hydrosorb® |
| Measure | Description | Time Frame |
|---|---|---|
| local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration. | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| skin colorimetry measured by a colorimeter | day0, day 7, day 14, day 21, day 28 | |
| pain level assessed by the visual analog pain scale | day0, day 7, day 14, day 21, day 28 | |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youlia Kirova, MD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France | |||
| Centre René Huguenin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26328937 | Result | Bazire L, Fromantin I, Diallo A, de la Lande B, Pernin V, Dendale R, Fourquet A, Savignoni A, Kirova YM. Hydrosorb(R) versus control (water based spray) in the management of radio-induced skin toxicity: Results of multicentre controlled randomized trial. Radiother Oncol. 2015 Nov;117(2):229-33. doi: 10.1016/j.radonc.2015.08.028. Epub 2015 Aug 29. |
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Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| quality of life assessed with the Dermatology Life Quality Index questionnaire |
| day0, day 14, day 28 |
| Saint-Cloud |
| 92210 |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |